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Updated: Jun 2, 2026
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Published on: December 5, 2025
Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective
Sabrine N T Hemmes1, Paolo Severgnini, Samir Jaber
1Department of Intensive Care Medicine & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, The Netherlands. s.hemmes@amc.uva.nl
Background:
Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery.
Methods:
The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO") trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH(2)O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH(2)O without recruitment maneuvers (the conventional strategy). The primary endpoint is any post-operative pulmonary complication.
Discussion:
The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications.
Trial Registration:
ISRCTN: ISRCTN70332574.
